U.S. patent number 11,219,722 [Application Number 16/289,471] was granted by the patent office on 2022-01-11 for needle-equipped outer tube.
This patent grant is currently assigned to TERUMO KABUSHIKI KAISHA. The grantee listed for this patent is TERUMO KABUSHIKI KAISHA. Invention is credited to Masaaki Kasai, Kozo Matsumoto, Tsutomu Sugiki.
United States Patent |
11,219,722 |
Matsumoto , et al. |
January 11, 2022 |
Needle-equipped outer tube
Abstract
A needle-equipped outer tube includes a needle; a joint member
that supports the needle, the needle being insert molded or
thermally welded to the joint member; and an outer tube including a
connection section, wherein the joint member is thermally welded to
the connection section of the outer tube.
Inventors: |
Matsumoto; Kozo (Nakakoma-gun,
JP), Kasai; Masaaki (Nakakoma-gun, JP),
Sugiki; Tsutomu (Nakakoma-gun, JP) |
Applicant: |
Name |
City |
State |
Country |
Type |
TERUMO KABUSHIKI KAISHA |
Tokyo |
N/A |
JP |
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Assignee: |
TERUMO KABUSHIKI KAISHA (Tokyo,
JP)
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Family
ID: |
1000006044522 |
Appl.
No.: |
16/289,471 |
Filed: |
February 28, 2019 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20190192787 A1 |
Jun 27, 2019 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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14260965 |
Apr 24, 2014 |
10258747 |
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PCT/JP2012/069545 |
Aug 1, 2012 |
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Foreign Application Priority Data
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Nov 2, 2011 [JP] |
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2011-241403 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M
5/344 (20130101); A61M 5/34 (20130101); A61M
5/346 (20130101); A61M 5/3202 (20130101); A61M
2207/00 (20130101) |
Current International
Class: |
A61M
5/34 (20060101); A61M 5/32 (20060101) |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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H01-11256 |
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Mar 1989 |
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JP |
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H09-276404 |
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Oct 1997 |
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JP |
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2004-154210 |
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Jun 2004 |
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JP |
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2005-342100 |
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Dec 2005 |
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JP |
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2005342100 |
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Dec 2005 |
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JP |
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2006116217 |
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May 2006 |
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JP |
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2008-006050 |
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Jan 2008 |
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JP |
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2011-011000 |
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Jan 2011 |
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JP |
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2011011000 |
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Jan 2011 |
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JP |
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WO 2008/139982 |
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Nov 2008 |
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WO |
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Other References
International Searching Authority, "International Search Report,"
issued in connection with International Patent Application No.
PCT/JP2012/069545, dated Sep. 18, 2012. cited by applicant .
International Searching Authority, "Written Opinion," issued in
connection with International Patent Application No.
PCT/JP2012/069545, dated Sep. 18, 2012. cited by applicant .
Extended European Search Report issued in Application No.
12845780.1 dated Apr. 20, 2015. cited by applicant .
English-Language Translation of the First Office Action issued in
Chinese Patent Application No. 201280053343.3 dated Sep. 29, 2015.
cited by applicant .
English-Language Translation of the Second Office Action issued in
Chinese Patent Application No. 201280053343.3 dated Jun. 3, 2016.
cited by applicant .
English-Language Translation of Rejection Decision issued in
Chinese Patent Application No. 201280053343.3 dated Dec. 27, 2016.
cited by applicant .
Communication pursuant to Article 94(3) EPC issued in European
Patent Application No. 12 845 780.1 dated Jul. 1, 2016. cited by
applicant .
English-Language Translation of Notification of Reason for Refusal
issued in Japanese Patent Application No. 2013-541656 dated Nov.
17, 2015. cited by applicant.
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Primary Examiner: Hall; Deanna K
Attorney, Agent or Firm: Foley & Lardner LLP
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a divisional of U.S. patent application Ser.
No. 14/260,965, filed on Apr. 24, 2014, which is a continuation
application of and claims the benefit of priority from
International Patent Application No. PCT/JP2012/069545, filed on
Aug. 1, 2012, which is based upon and claims the benefit of
priority of Japanese Application No. 2011-241403 filed on Nov. 2,
2011. The contents of these applications are incorporated herein by
reference in their entireties.
Claims
What is claimed is:
1. A needle-equipped outer tube comprising: a needle; a transparent
joint member that supports the needle, the needle being insert
molded or thermally welded to the transparent joint member; and a
transparent outer tube including a connection section, wherein the
transparent joint member is thermally welded to the connection
section of the transparent outer tube at a thermally welded portion
such that a uniform and transparent boundary surface is formed
between the transparent joint member and the connection section
without foaming at the thermally welded portion.
2. The needle-equipped outer tube according to claim 1, wherein a
connection between the transparent joint member and the connection
section is a connection formed by thermally welding the transparent
joint member to the connection section while the transparent joint
member is pressed against the connection section in an axial
direction of the transparent outer tube.
3. The needle-equipped outer tube according to claim 2, wherein the
transparent joint member includes a press force receiving surface
from which the needle protrudes, the press force receiving surface
being configured to be pressed during said thermal welding.
4. The needle-equipped outer tube according to claim 1, wherein a
first end portion of the needle is arranged in the connection
section of the transparent outer tube.
5. The needle-equipped outer tube according to claim 1, wherein a
material of which the joint member is formed is substantially the
same as a material of which the outer tube is formed.
6. The needle-equipped outer tube according to claim 5, wherein the
material of which the joint member is formed is the same as the
material of which the outer tube is formed.
7. The needle-equipped outer tube according to claim 6, wherein the
joint member and the outer tube each comprise a cyclic polyolefin
material.
Description
BACKGROUND
Technical Field
The present disclosure relates to a method for manufacturing a
needle-equipped outer tube in which a needle of a syringe is
directly joined to a distal end of an outer tube of the syringe in
advance, and to the needle-equipped outer tube.
Background Art
Conventionally, in some outer tubes having a small volume used for
insulin administration or vaccination, a needle is previously
joined to the outer tube. Such a needle-equipped outer tube is
manufactured by joining the needle to the distal end of the outer
tube with an epoxy adhesive, a UV-curing type adhesive, or the like
(see, e.g., Japanese Examined Utility Model Application Publication
No. 1-11256 (hereinafter "JP '256")). Further, there is a
needle-equipped outer tube manufactured by joining a needle to the
distal end of the outer tube by insert molding (see, e.g., PCT
Publication No. WO 2008/139982 A (hereinafter "WO '982")).
Besides the above, a prefilled syringe in which a medicine is
previously filled in the outer tube is frequently used. Further, a
needle-equipped outer tube in which a medicine is previously filled
is proposed.
However, in JP '256, in which a needle is joined to the distal end
of the outer tube by an adhesive, the adhesive may make contact
(liquid contact) with a medicine which is previously filled in the
outer tube of the needle-equipped outer tube, which may have a
negative effect on the medicine. Therefore, there is a need for a
technique to integrally form a needle and an outer tube with a
novel joining method not using an adhesive.
Further, in WO '982, in which a needle is joined to the distal end
of the outer tube by insert molding, a mechanism for arranging the
needle in the cavity of the mold is necessary (e.g., a mechanism
for inserting and removing a rod for attachment). Therefore, the
molding machine and supplementary equipment thereof needed to
manufacture such a device are complex and large.
SUMMARY OF INVENTION
One object of the present invention is to provide a method for
manufacturing a needle-equipped outer tube in which a needle is
joined to an outer tube with compact equipment and without using an
adhesive, and a needle-equipped outer tube manufactured by the
method for manufacturing a needle-equipped outer tube.
In one embodiment, a method for manufacturing a needle-equipped
outer tube is provided. A needle, a joint member having a needle
insertion hole in which the needle can be inserted, and an outer
tube provided with a connection section at one of end portions in
the axial direction are prepared. Further, the joint member, in
which the needle is inserted in the needle insertion hole, engaging
with the connection section is pressed toward the connection
section by a pressing member, and under this state, the needle and
the joint member as well as the joint member and the connection
section are thermally welded to manufacture the needle-equipped
outer tube.
The method for manufacturing a needle-equipped outer tube includes,
for example, an engagement process, an assembling process, and a
welding process.
In the engagement process, the joint member engages with the
connection section provided at one of end portions in the axial
direction of the outer tube.
In the assembling process, the needle is inserted in the needle
insertion hole formed in the joint member.
In the welding process, the joint member is pressed along the axial
direction of the outer tube by the pressing member, and under this
state, the joint member and the needle as well as the joint member
and the connection section are thermally welded.
In such method for manufacturing a needle-equipped outer tube, the
joint member and the needle as well as the joint member and the
connection section of the outer tube are joined by thermal welding,
so that the needle is fixed to the outer tube without using an
adhesive. Further, since the joint member is pressed along the
axial direction of the outer tube during the thermal welding, the
thermal welding is carried out with no air existing between the
joint member and the connection section of the outer tube.
Consequently, foaming in the joint section (thermally welded
section) can be prevented, thereby preventing deterioration in
aesthetic of the needle-equipped outer tube.
Further, the method for manufacturing a needle-equipped outer tube
may include, for example, an insert molding process, an engagement
process, and a welding process.
In the insert molding process, the needle and the joint member
which supports the needle are integrally formed by insert
molding.
In the engagement process, the joint member supporting the needle
engages with the connection section provided at the end portion in
the axial direction of the outer tube.
In the welding process, the joint member is pressed along the axial
direction of the outer tube by the pressing member, and under this
state, the joint member and the connection section is thermally
welded.
In the method for manufacturing a needle-equipped outer tube as
described above, the joint member supporting the needle is joined
to the connection section of the outer tube by thermal welding, so
that the needle can be fixed to the outer tube without using an
adhesive. Further, since the joint member is pressed along the
axial direction of the outer tube during the thermal welding, the
joint member and the connection section are thermally welded with
no air existing between the joint member and the connection section
of the outer tube. Consequently, foaming in the joint section
(thermally welded section) can be prevented, thereby preventing
deterioration in the appearance of the needle-equipped outer
tube.
The needle-equipped outer tube according to an embodiment of the
present invention includes the needle, the joint member supporting
the needle, and the outer tube.
The outer tube includes the connection section which engages with,
and is joined to, the joint member.
Further, the joint member engaging with the connection section of
the outer tube is pressed along the axial direction of the outer
tube, and under this state, the joint member is joined to the
connection section by thermal welding.
The needle and the joint member of the needle-equipped outer tube
are joined by thermal welding or insert molding. Further, since the
joint member and the connection section of the outer tube are
joined by thermal welding, the needle is fixed to the outer tube
without using an adhesive.
The method for manufacturing a needle-equipped outer tube and the
needle-equipped outer tube provide high joint strength without
deteriorating the appearance since the boundary surface between the
joint member and the connection section becomes uniform and
transparent. Further, since the joint member is pressed toward the
connection section during the joining process, the air existing
between the joint member which is heat melted and the connection
section is discharged from the space between the joint member and
the connection section. Further, by suitably setting the heating
temperature, foaming in the joint member and the connection section
(resin) is prevented. As a result, problems such as reduced
strength, contamination, and permeation of a medicine caused by the
air existing between the joint member and the connection section
can be prevented. Further, since the joint member can be made
relatively small, equipment for insert molding the needle and the
joint member can be downsized.
By the method for manufacturing a needle-equipped outer tube and
the needle-equipped outer tube according to embodiments of the
present invention, the needle can be joined to the outer tube with
compact equipment without using an adhesive.
BRIEF DESCRIPTION OF DRAWINGS
FIG. 1 is a perspective view of a needle-equipped outer tube
according to a first embodiment.
FIG. 2 is an exploded perspective view of the needle-equipped outer
tube of the first embodiment.
FIG. 3 is a perspective view illustrating a state in which a cap is
attached to the needle-equipped outer tube of the first
embodiment.
FIG. 4 is a cross sectional view of the needle-equipped outer tube
and the cap illustrated in FIG. 3.
FIG. 5 is an explanatory drawing explaining a method for
manufacturing the needle-equipped outer tube of the first
embodiment.
FIG. 6 is a cross sectional view illustrating a needle stopping
portion of the needle-equipped outer tube of the first
embodiment.
FIG. 7 is a cross sectional view illustrating a needle supporting
portion used in the method for manufacturing a needle-equipped
outer tube.
FIG. 8 is a perspective view of a needle-equipped outer tube
according to a second embodiment.
FIG. 9 is an exploded perspective view of needle-equipped outer
tube of the second embodiment.
FIG. 10 is an explanatory drawing explaining a method for
manufacturing the needle-equipped outer tube of the second
embodiment.
FIG. 11 is an explanatory drawing of a needle-equipped outer tube
according to a third embodiment.
FIG. 12 is an explanatory drawing of a needle-equipped outer tube
according to a fourth embodiment.
FIG. 13 is an explanatory drawing of a needle-equipped outer tube
according to a fifth embodiment.
FIG. 14 is an explanatory drawing of a needle-equipped outer tube
according to a sixth embodiment.
FIG. 15 is an explanatory drawing of a needle-equipped outer tube
according to a seventh embodiment.
DETAILED DESCRIPTION
The needle-equipped outer tube according to embodiments of the
present invention will be described below referring to FIG. 1 to
FIG. 15. Note that, in each of the drawings, the same component is
indicated with the same reference numeral. Further, the present
invention is not limited to the embodiments described below.
Note that, the description will be made in the order listed below.
1. First embodiment of the needle-equipped outer tube Configuration
of a needle-equipped outer tube Method for manufacturing a
needle-equipped outer tube 2. Second embodiment of the
needle-equipped outer tube Configuration of a needle-equipped outer
tube Method for manufacturing a needle-equipped outer tube 3. Third
embodiment of the needle-equipped outer tube 4. Fourth embodiment
of the needle-equipped outer tube 5. Fifth embodiment of the
needle-equipped outer tube 6. Sixth embodiment of the
needle-equipped outer tube 7. Seventh embodiment of the
needle-equipped outer tube
1. First Embodiment of the Needle-Equipped Outer Tube
<Configuration of a Needle-Equipped Outer Tube>
First, the configuration of the first embodiment of the
needle-equipped outer tube will be described referring to FIG. 1
and FIG. 2.
FIG. 1 is a perspective view of the first embodiment of the
needle-equipped outer tube. FIG. 2 is an exploded perspective view
of the first embodiment of the needle-equipped outer tube.
The needle-equipped outer tube 1 is used to carry out piercing from
the surface of a skin with a needle tip so as to inject a medicine
into a living body. As illustrated in FIG. 1, the needle-equipped
outer tube 1 includes a needle 2, a joint member 3 to which the
needle 2 is joined, and an outer tube 4 to which the joint member 3
is joined. Further, a cap 5 (see FIG. 3 and FIG. 4) is attached to
the needle-equipped outer tube 1.
[Needle]
First, the needle 2 will be described.
A needle having a gauge size of 10 to 33 (outer diameter of .PHI.
3.5 to 0.2 mm) according to ISO standards for medical needles
(ISO9626:1991/Amd. 1:2001(E)) is used as the needle 2. Preferably,
a needle having a gauge size of 16 to 33 (outer diameter of .PHI.
1.7 to 0.2 mm) is used.
At one of the ends (in the axial direction) of the needle 2, a
needle tip 2a which is pierced into a living body is provided. The
needle tip 2a has a sharp acute angle forming a bladed edge.
Hereinafter, the other end of the needle 2, that is, the end on the
side opposite the needle tip 2a, will be referred to as the
"proximal end" 2b (see FIG. 2). The needle tip 2a of the needle 2
protrudes from a distal end surface 11a of the joint member 3. The
proximal end 2b of the needle 2 protrudes from a rear end surface
12a of the joint member 3. The proximal end 2b of the needle 2 is
arranged in a connection section 16 of the outer tube 4.
The middle portion of the needle 2 is inserted in a tubular hole 3a
of the joint member 3. The surface of the middle portion of the
needle 2 is formed to have a rough surface by applying blasting or
the like. In this manner, when the needle 2 and the joint member 3
are joined by thermal welding, the joint strength between the
needle 2 and the joint member 3 can be improved by the softened
(melted) resin making tight contact with the rough surface of the
needle 2. Further, by the softened (melted) resin making tight
contact with the rough surface of the needle 2, fluid tightness can
be improved. Note that, the surface of the needle 2 may be finished
to have a roughness (Ra) of 1.0 to 3.0, preferably, 1.3 to 2.0, by
blasting or the like.
As a material of the needle 2, for example, a stainless steel may
be used. However, the material is not limited to a stainless steel.
Aluminum, an aluminum alloy, titanium, a titanium alloy, or other
metals may be used. Further, as for the needle 2, not only a
straight needle but also a tapered needle in which at least a
portion is tapered can be used. The tapered needle may have a
proximal end portion having a diameter larger than that of the end
portion of the needle tip 2a, and a middle portion configured as a
tapered structure. Further, the cross sectional shape of the needle
2 is not limited to a circle, and may also be a polygon such as a
triangle.
Further, to the portion of the surface of the needle 2 close to the
needle tip 2a, a coating material composed of, for example, a
silicone resin, a fluorine-based resin, or the like is applied. In
this manner, the friction between the skin and the needle 2
produced when the needle 2 is pierced into a living body can be
reduced, which can ease a pain during the piercing.
[Joint Member]
Now, the joint member 3 will be described.
As illustrated in FIG. 2, the joint member 3 is formed in an
approximately cylindrical shape having a tubular hole (needle
insertion hole) 3a in which the needle 2 is inserted. The diameter
of the tubular hole 3a is provided to be larger than the outer
diameter of the needle 2 by about 0.01 to 0.08 mm, preferably, by
about 0.01 to 0.03 mm.
The joint member 3 is configured with a distal end side tubular
portion 11 and a rear end side tubular portion 12 having an outer
diameter smaller than that of the distal end side tubular portion
11.
The distal end side tubular portion 11 is formed in a cylindrical
shape having a uniform outer diameter. On the end portion of the
distal end side tubular portion 11, opposite to the rear end side
tubular portion 12, a distal end surface 11a is formed. The distal
end surface 11a is a press force receiving surface which is pressed
by a pressing portion 101a of a pressing apparatus 101 which will
be described below.
On the end portion of the rear end side tubular portion 12,
opposite to the distal end side tubular portion 11, a rear end
surface 12a is formed. The rear end side tubular portion 12 is
formed in a tapered shape in which the outer diameter gradually
decreases toward the rear end surface 12a.
As a material of the joint member 3, various types of resin such as
polyvinyl chloride, polyethylene, polypropylene, cyclic polyolefin,
polystyrene, poly(4-methylpentene-1), polycarbonate, acrylic resin,
acrylonitrile-butadiene-styrene copolymer, polyester such as
polyethylene-telephthalate, butadiene-styrene copolymer, and
polyamide (e.g., nylon 6, nylon 6,6, nylon 6,10, nylon 12) may be
used. Among those, a resin such as polypropylene, cyclic
polyolefin, polyester, and poly(4-methylpentene-1) is preferably
used. Note that, it is preferable that the material of the joint
member 3 is substantially transparent so that the inside of the
joint member 3 is visible.
[Outer Tube]
Now, the outer tube 4 will be described.
The outer tube 4 includes an outer tube body 15 in which a medicine
is filled and a connection section 16 to which the joint member 3
is joined. The outer tube body 15 is formed in an approximately
cylindrical shape having a tubular hole 15a (see FIG. 4). The
connection section 16 is provided at an end portion 15b in the
axial direction of the outer tube body 15 and a flange 17 is formed
on the other end portion 15c.
When the needle-equipped outer tube 1 is used as an ordinary
syringe, a pusher and a gasket (not shown in the drawing) are
inserted from the other end portion 15c side of the outer tube body
15. Further, when the needle-equipped outer tube 1 is used as a
prefilled outer tube, a pusher and a gasket are inserted from the
other end portion 15c side after a medicine is filled in the
tubular hole 15a of the outer tube body 15.
A medicine to be filled in the tubular hole 15a of the outer tube
body 15 may be any medicine which is usually used as an injection,
for example, a protein drug such as an antibody, a peptide
pharmaceutical such as a hormone, a nucleic acid medicine, a
cellular medicine, a blood product, a vaccine for preventing
infections, an anticancer agent, an anesthetic, a drug, an
antibiotic, a steroid, a proteolytic enzyme inhibitor, a heparin, a
saccharide injection such as a glucose, an injection for correcting
electrolyte imbalance such as sodium chloride and potassium
lactate, a vitamin compound, a fat emulsion, a contrast media, and
a stimulant.
Note that, in the embodiment, description is made for an example in
which the shape of the outer tube body 15 is formed in an
approximately cylindrical shape, though the shape of the outer tube
body 15 may be a hollow quadrangular prism shape or a hexagonal
prism shape.
The connection section 16 is configured with a tapered engagement
portion 18 which is continued to the end portion 15b of the outer
tube body 15 and a distal end side engagement portion 19 which is
continued to the tapered engagement portion 18.
The tapered engagement portion 18 has an approximately cross-shaped
cross section in a plane perpendicular to the axial direction of
the outer tube 4, and an engagement hole 18a having a circular
cross section (see FIG. 4 and FIG. 5). The engagement hole 18a is
formed in a tapered shape (tapered inner shape) in which the
diameter gradually decreases toward the end portion 15b of the
outer tube body 15. The rear end side tubular portion 12 of the
joint member 3 is inserted in the engagement hole 18a.
The rear end side tubular portion 12 is formed in a tapered shape
(tapered outer shape) so as to engage with the engagement hole 18a.
Further, taper angles of the engagement hole 18a and the rear end
side tubular portion 12 are not particularly limited, though an
angle of 1 to 3 degrees is preferable.
The distal end side engagement portion 19 has an approximately
circular cross section in a plane perpendicular to the axial
direction of the outer tube 4, and an engagement hole 19a (see FIG.
3). The distal end side tubular portion 11 of the joint member 3 is
inserted in the engagement hole 19a. Note that, the diameter of the
engagement hole 19a is approximately the same as the outer diameter
of the distal end side tubular portion 11 of the joint member
3.
As a material of the outer tube 4 configured with the connection
section 16 and the outer tube body 15, a resin similar to that used
for the joint member 3 is preferably used. Note that, it is
preferable that the material of the outer tube 4 is substantially
transparent so that the inside of the outer tube 4 is visible.
Further, the connection section 16 of the outer tube 4 and the
joint member 3 are joined by thermal welding. Therefore, it is
preferable that the material of the outer tube 4 is substantially
the same as the material of the joint member 3. In this manner,
preferable bondability between the connection section 16 and the
joint member 3 can be obtained so that the connection section 16
and the joint member 3 can firmly be fixed. Further, the welded
portion between the connection section 16 and the joint member 3
can be made inconspicuous so that aesthetic of the needle-equipped
outer tube 1 can be improved.
[Cap]
Now the cap 5 will be described referring to FIG. 3 and FIG. 4.
FIG. 3 is a perspective view illustrating a state in which the cap
5 is attached to the needle-equipped outer tube 1. FIG. 4 is a
cross sectional view illustrating the needle-equipped outer tube 1
and the cap 5 illustrated in FIG. 3.
As illustrated in FIG. 3 and FIG. 4, the cap 5 is formed in an
approximately cylindrical shape with one end in the axial direction
opened and the other end in the axial direction closed. The cap 5
is formed of a flexible member, for example, a rubber or an
elastomer.
The cap 5 is attached to the connection section 16 of the outer
tube 4 so as to cover the needle tip 2a of the needle 2 and the
connection section 16 of the outer tube 4. Further, as illustrated
in FIG. 4, a portion of the needle 2 in the needle tip 2a side and
the connection section 16 are inserted into the tubular hole 5a of
the cap 5.
Note that, the inner diameter of the tubular hole 5a of the cap 5
is provided to be approximately the same as, or slightly smaller
than, the outer diameter of the distal end side engagement portion
19 of the connection section 16. Therefore, when the cap 5 is
attached to the connection section 16, the outer circumferential
surface of the distal end side engagement portion 19 makes tight
contact with the inner circumferential surface of the cap 5. In
this manner, the space around the needle 2 protruding from the
joint member 3 is sealed by the distal end side engagement portion
19 and the inner circumferential surface of the cap 5. As a result,
adhering of germs to the needle tip 2a can be prevented.
Further, the inner circumferential surface of the cap 5 compresses
the boundary portion (narrow portion) between the distal end side
engagement portion 19 and the tapered engagement portion 18 of the
connection section 16 by the elastic force of the cap 5. In this
manner, the inner circumferential surface of the cap 5 and the
narrow portion of the connection section 16 engage with each other,
thereby preventing the cap 5 from coming off from the connection
section 16 (outer tube 4) during transportation.
<Method for Manufacturing a Needle-Equipped Outer Tube>
Now, a method for manufacturing the needle-equipped outer tube 1
will be described referring to FIG. 5 and FIG. 6.
FIG. 5 is an explanatory drawing explaining the method for
manufacturing the needle-equipped outer tube 1. FIG. 6 is a cross
sectional view illustrating a needle stopping portion of the
needle-equipped outer tube 1.
When manufacturing the needle-equipped outer tube 1, at first, each
of the needle 2, the joint member 3 and the outer tube 4 is
prepared. The needle 2 is formed in a desired tubular body by, for
example, press working of a metal plate or swaging process of a
hollow pipe. Each of the joint member 3 and the outer tube 4 is
formed by injection molding. By separately forming the joint member
3 and the outer tube 4 in this manner, a mold can be made small and
simple.
[Engagement Process]
Next, an engagement process is carried out. In the engagement
process, the joint member 3 is inserted into the engagement holes
18a and 19a of the connection section 16 of the outer tube 4. In
this manner, the rear end side tubular portion 12 of the joint
member 3 engages with the tapered engagement portion 18 of the
connection section 16, and at the same time, the distal end side
tubular portion 11 of the joint member 3 engages with the distal
end side engagement portion 19 of the connection section 16.
[Assembling Process]
Next, the assembling process will be carried out. In the assembling
process, the needle 2 is inserted in the tubular hole 3a of the
joint member 3. In the process, the proximal end 2b of the needle 2
makes contact with a needle stopping portion 21 provided in the
connection section 16 of the outer tube 4 (see FIG. 6). In this
manner, the needle 2 is positioned against the joint member 3 and
the outer tube 4 and the proximal end 2b of the needle 2 is
arranged in the connection section 16. In other words, the proximal
end 2b of the needle 2 is not arranged in the tubular hole 15a of
the outer tube body 15. Consequently, the dead volume in the outer
tube 4 can be reduced, thereby reducing the amount of medicine
remaining in the outer tube 4.
As illustrated in FIG. 6, the needle stopping portion 21 is formed
in a ring shaped protrusion which protrudes from the inner surface
of the tapered engagement portion 18. A communication hole 21a
provided in the center of the needle stopping portion 21 makes
communication between the tubular hole 15a of the outer tube body
15 and engagement holes 18a and 19a of the connection section 16.
Therefore, a needle hole of the needle 2 which is positioned by
making contact with the needle stopping portion 21 communicates
with the tubular hole 15a of the outer tube body 15 via the
communication hole 21a.
For example, when a 27G needle is applied as the needle 2, the
outer diameter of the needle 2 is .PHI. 0.41 mm and the inner
diameter is .PHI. 0.19 to 0.25 mm. In this case, the diameter of
the communication hole 21a of the needle stopping portion 21 is
preferably be .PHI. 0.26 to 0.4 mm.
[Welding Process]
Next, a welding process is carried out. In the welding process, the
distal end surface 11a of the joint member 3 is pressed along the
axial direction of the outer tube 4 by the pressing apparatus 101,
and under this state, the joint member 3 and the needle 2 as well
as the joint member 3 and the connection section 16 of the outer
tube 4 are joined by thermal welding.
The pressing apparatus 101 includes a pressing portion 101a which
presses the distal end surface 11a of the joint member 3. By
applying pressure to the joint member 3 by the pressing portion
101a, the outer circumferential surface of the rear end side
tubular portion 12 and the inner circumferential surface of the
tapered engagement portion 18 can be kept in tight contact with
each other.
In the embodiment, the thermal welding is carried out using a high
frequency induction heating apparatus 110. The high frequency
induction heating apparatus 110 includes a work coil 111 and a
power source 112 which supplies an AC current to the work coil
111.
When the power source 112 supplies an AC current to the work coil
111, a magnetic field is generated around the work coil 111 and an
eddy current is produced in the needle 2. Therefore, the
temperature of the needle 2 rises to heat the joint member 3. Then
the joint member 3 softens to adhere to the needle 2 and the
connection section 16 of the outer tube 4. As a result, the joint
member 3 and the needle 2 as well as the joint member 3 and the
connection section 16 of the outer tube 4 are joined by thermal
welding and thereby, the needle-equipped outer tube 1 is
manufactured.
Note that, when the thickness of the joint member 3 is provided to
be 0.4 to 0.55 mm, it is preferable to set the output of the power
source 112 to be 46 to 52 V with 2.5 to 3.2 A and the oscillation
period of the work coil 111 to be 4 to 10 seconds (s). Further, the
pressing force applied to the joint member 3 is preferably set to
be 50 to 100 N.
The condition mentioned above is the case where cyclic olefin
polymer (COP) being cyclic polyolefin is used as the material of
the joint member, though a condition should be determined to give a
suitable resin temperature according to the characteristic of the
resin to be used, so as to prevent occurring of foaming, a burnt
resin, and deformation.
In the embodiment, since the joint member 3 and the needle 2 as
well as the joint member 3 and the outer tube 4 are joined using
the high frequency induction heating apparatus 110, the needle 2 is
fixed to the outer tube 4 without using an adhesive.
Further, in the embodiment, since the thermal welding is carried
out with the joint member 3 pressed along the axial direction of
the outer tube 4 by the pressing apparatus 101, no gap is produced
between the joint member 3 and the connection section 16 of the
outer tube 4. In this manner, foaming will not occur in the joint
member 3 when the joint member 3 is heated. As a result,
transparency is provided to the joint section without deteriorating
aesthetic, and at the same time, the joint member 3 and the needle
2 as well as the joint member 3 and the connection section 16 of
the outer tube 4 can tightly be fixed.
Further, since the surface of the portion, inserted in the joint
member 3, of the needle 2 is formed in a rough surface by blasting
or the like, the softened resin (joint member 3) makes tight
contact with the rough surface of the needle 2. As a result, joint
strength as well as fluid tightness between the needle 2 and the
joint member 3 can be improved.
Further, since the insert molding is not used in the embodiment, a
complex and large insert molding apparatus is not necessary so that
an excellent needle-equipped outer tube can be manufactured with
low cost.
[Comparative Experiment]
Now, the description will be made for a comparative experiment in
which cases with and without pressing of the joint member 3 in the
welding process using the high frequency induction heating
apparatus 110 are compared.
The work coil 111 having an average wire diameter of .PHI. 4.3 mm
and an average coil inner diameter of .PHI. 9 mm is used. The power
source 112 is set to output 5 kW with 2 MHz. Further, the work coil
is positioned in the middle of the joining section, specifically,
in a location 5 to 6 mm from the distal end (distal end side
engagement portion 19 side) of the connection section 16. The
needle 2 of 27G is used and the thickness of the joint member 3 is
provided to be 0.47 mm. Further, taper angles of the engagement
hole 18a and the rear end side tubular portion 12 are provided to
be 1.6 degrees.
The experiment is evaluated by "external appearance" and "joint
strength". The "external appearance" is evaluated to be good
(.largecircle.) when there is no foaming or burning and the length
of the welded section is 2 mm or more. Further, "joint strength" is
expressed by force (N) required to remove the joint member 3 from
the connection section 16 of the outer tube 4. It is sufficient to
have the "joint strength" of 50 N or higher, preferably, 80 to 120
N.
The result of the comparative experiment is shown in Table 1.
TABLE-US-00001 TABLE 1 Welding condition Result of welding High
frequency output Welding External Joint Voltage Current Time
pressure appear- strength (V) (A) (sec) (N) ance (N) Example 1 52
3.2 4 60 .largecircle. 110 Example 2 46 2.5 10 60 .largecircle. 110
Comparative 52 3.2 4 0 X 50 example 1 (Foaming)
As shown in Table 1, evaluations of "external appearance" for
Example 1 and Example 2 which include pressing of the joint member
3 are good (.largecircle.). And "joint strength" is 110 N.
Contrarily, for Comparative example 1 which doesn't include
pressing of the joint member 3, the evaluation of "external
appearance" is not good (x) since foaming occurred in the welded
portion. And "joint strength" is 50 N.
According to the comparative experiment, the case in which thermal
welding is carried out with the joint member 3 pressed resulted in
better "external appearance" and higher "joint strength" than the
case in which the joint member 3 is not pressed. Note that, it can
be understood that in Comparative example 1, the foaming occurred
in the welded portion resulting in reduction of the length of the
welded portion to be less than 2 mm, thereby reducing "joint
strength".
[Exemplary Modification]
As illustrated in FIG. 6, in the embodiment, the proximal end 2b of
the needle 2 is made to contact the needle stopping portion 21 of
the outer tube 4 to position the needle 2 during the assembling
process. However, the positioning of the needle 2 is not limited to
the manner using the needle stopping portion 21, and may be carried
out by, for example, a member other than the needle-equipped outer
tube 1.
FIG. 7 is a cross sectional view illustrating a needle supporting
member used in the method for manufacturing a needle-equipped outer
tube of the present invention.
As illustrated in FIG. 7, the needle supporting member 102 includes
a base portion 102a arranged in the tubular hole 15a of the outer
tube body 15 and a support protrusion 102b which protrudes from the
upper end of the base portion 102a and supports the proximal end 2b
of the needle 2.
The support protrusion 102b of the needle supporting member 102 is
inserted in the engagement hole 18a of the connection section 16.
Therefore, the proximal end 2b of the needle 2 supported by the
support protrusion 102b is arranged in the connection section 16.
In other words, the needle 2 is not arranged in the tubular hole
15a of the outer tube body 15. Consequently, the dead volume in the
outer tube 4 can be reduced, thereby reducing the amount of
medicine remaining in the outer tube 4.
Further, as for an exemplary modification for minimizing the dead
volume, the distal end of the needle supporting member 102 may be
formed flat so as to block the engagement hole 18a of the
connection section 18.
2. Second Embodiment of the Needle-Equipped Outer Tube
<Configuration of a Needle-Equipped Outer Tube>
Now, the second embodiment of the needle-equipped outer tube will
be described referring to FIG. 8 and FIG. 9.
FIG. 8 is a perspective view of the second embodiment of the
needle-equipped outer tube. FIG. 9 is an exploded perspective view
of the second embodiment of the needle-equipped outer tube.
A needle-equipped outer tube 31 has a configuration similar to that
of the needle-equipped outer tube 1 of the first embodiment (see
FIG. 1). The needle-equipped outer tube 31 is different from the
needle-equipped outer tube 1 in that the needle 2 and the joint
member 3 are integrally formed in advance by insert molding, and in
the shape of an outer tube 34.
As illustrated in FIG. 8 and FIG. 9, the needle-equipped outer tube
31 includes a needle block 32 and the outer tube 34 to which the
needle block 32 is joined. Further, the cap 5 (see FIG. 3 and FIG.
4) is attached to the needle-equipped outer tube 31.
[Needle Block]
Now, the needle block 32 will be described.
The needle block 32 includes the needle 2 and the joint member 3
which supports the needle 2. The needle 2 and the joint member 3
are integrally formed by insert molding.
The needle tip 2a of the needle 2 of the needle block 32 protrudes
from the distal end surface 11a of the joint member 3, and the
proximal end 2b of the needle 2 protrudes from the rear end surface
12a of the joint member 3 and is arranged in a connection section
46, which will be described below, of the outer tube 34. The
distance from the rear end surface 12a of the joint member 3 to the
proximal end 2b of the needle 2 is determined so as the proximal
end 2b of the needle 2 not to be inserted in the tubular hole 15a
(see FIG. 10) of the outer tube body 15 of the outer tube 34.
[Outer Tube]
Next, the outer tube 34 will be described.
The outer tube 34 includes the outer tube body 15 in which a
medicine is filled and the connection section 46 to which the joint
member 3 of the needle block 32 is joined.
The connection section 46 is configured with a tapered engagement
portion 48 which is continued to the end portion 15b of the outer
tube body 15 and the distal end side engagement portion 19 which is
continued to the tapered engagement portion 48.
The tapered engagement portion 48 is formed in a truncated conical
shape. The diameter of the tapered engagement portion 48 gradually
decreases toward the distal end side engagement portion 19.
Therefore, the tapered engagement portion 48 is formed so as that
the cross section perpendicular to the axial direction of the outer
tube 34 is a near circle.
Further, the tapered engagement portion 48 includes an engagement
hole 48a which communicates with the engagement hole 19a of the
distal end side engagement portion 19. The engagement hole 48a is
formed in a tapered shape (tapered inner shape) in which the
diameter gradually decreases toward the end portion 15b of the
outer tube body 15. The rear end side tubular portion 12 of the
joint member 3 is inserted in the engagement hole 48a.
The rear end side tubular portion 12 is formed in a tapered shape
(tapered outer shape) so as to engage with the engagement hole 48a.
Further, taper angles of the engagement hole 48a and the rear end
side tubular portion 12 are not particularly limited, though angle
of 1 to 3 degrees is preferable.
Conventionally, a connection section of an outer tube and a needle
are integrally formed by insert molding. In a case of carrying out
injection molding (insert molding), a shrink mark is likely to
occur in a thick region. Therefore, when the connection section of
the outer tube and the needle are integrally formed by insert
molding, the cross section is made, for example, in a cross-shape,
so as to restrain the thickness of the connection section.
However, in the needle-equipped outer tube according to the present
invention, the portion which supports the needle is formed by
joining the connection section of the outer tube and a joint member
provided separately from the connection section. Therefore, the
thickness of the tapered engagement portion 48 of the connection
section 46 of the embodiment of the present invention is restrained
even when the tapered engagement portion 48 has a conical shape
(column shape). Consequently, even when the tapered engagement
portion 48 has a conical shape (column shape), generation of a
shrink mark can be prevented or restrained.
In the embodiment, the cap 5 (see FIG. 4) can be made to tightly
contact the tapered engagement portion 48 since the tapered
engagement portion 48 is provided in a conical shape (column
shape). As a result, sealability in the cap 5 can be provided so
that the inside of the cap 5 can be kept clean. Further, the cap 5
is further securely assembled, since the cap 5 (see FIG. 4) tightly
contacts the tapered engagement portion 48.
<Method for Manufacturing a Needle-Equipped Outer Tube>
Next, the method for manufacturing the needle-equipped outer tube
31 will be described referring to FIG. 10.
FIG. 10 is an explanatory drawing explaining the method for
manufacturing the needle-equipped outer tube 1.
When the needle-equipped outer tube 31 is manufactured, firstly,
the needle 2 and the outer tube 34 are prepared. The needle 2 is
formed in a desired tubular body by, for example, press working of
a metal plate or swaging process of a hollow pipe. The outer tube
34 is formed by, for example, injection molding.
[Insert Molding Process]
Next, the insert molding process will be described. In the insert
molding process, the needle 2 and the joint member 3 are integrally
formed by insert molding. Thereby, the needle block 32 is
manufactured. Since the needle block 32 and the outer tube 34 are
separately molded in this manner, a mold and a molding apparatus
can be downsized.
[Engagement Process]
Next, an engagement process is carried out. In the engagement
process, the joint member 3 of the needle block 32 is inserted in
the engagement holes 48a and 19a of the connection section 46 of
the outer tube 4. In this manner, the rear end side tubular portion
12 of the joint member 3 engages with the tapered engagement
portion 48 of the connection section 46 and at the same time, the
distal end side tubular portion 11 of the joint member 3 engages
with the distal end side engagement portion 19 of the connection
section 46.
Thereby, the needle 2 of the needle block 32 is positioned against
the outer tube 34 and the proximal end 2b of the needle 2 is
arranged in the connection section 46. In other words, the proximal
end 2b of the needle 2 is not arranged in the tubular hole 15a of
the outer tube body 15. As a result, the dead volume in the outer
tube 34 can be reduced, thereby reducing the amount of medicine
remaining in the outer tube 34.
[Welding Process]
Next, a welding process is carried out. In the welding process, the
distal end surface 11a of the joint member 3 is pressed along the
axial direction of the outer tube 34 by the pressing apparatus 101,
and under this state, the joint member 3 of the needle block 32 and
the connection section 16 of the outer tube 34 are joined by
thermal welding.
By applying pressure to the joint member 3 by the pressing portion
101a of the pressing apparatus 101, the outer circumferential
surface of the rear end side tubular portion 12 and the inner
circumferential surface of the tapered engagement portion 48 can be
kept in tight contact with each other.
In the embodiment, a semiconductor laser irradiation apparatus 120
is used to carry out thermal welding. The joint section of the
needle 2 of the needle block 32 is irradiated with a laser by the
semiconductor laser irradiation apparatus 120. Therefore, the
temperature of the needle 2 rises to heat the joint member 3. Then,
the joint member 3 softens to adhere to the needle 2 and the
connection section 46 of the outer tube 34. As a result, the joint
member 3 and the needle 2 as well as the joint member 3 and the
connection section 46 of the outer tube 34 are joined by thermal
welding and thereby, the needle-equipped outer tube 31 is
manufactured.
Note that, when the thickness of the joint member 3 is provided to
be 0.4 to 0.55 mm, it is preferable to set the output of the
semiconductor laser irradiation apparatus 120 to be 15 to 25 W and
the irradiation time of a laser to be 1.5 to 3 seconds (s).
Further, as for an optical system, a focus diameter is preferably
set to be .PHI. 2.5 to 4 mm. Further, the pressing force applied to
the joint member 3 is preferably set to be 50 to 100 N.
The condition mentioned above is the case where cyclic olefin
polymer (COP) being cyclic polyolefin is used as the material of
the joint member, though a condition should be determined to give a
suitable resin temperature according to the characteristic of the
resin to be used, so as to prevent occurring of foaming, a burnt
resin, and deformation.
In the embodiment, since the joint member 3 and the needle 2 as
well as the joint member 3 and the outer tube 34 are joined by
using the semiconductor laser irradiation apparatus 120, the needle
2 is fixed to the outer tube 34 without using an adhesive.
Further, in the embodiment, since the thermal welding is carried
out with the joint member 3 pressed along the axial direction of
the outer tube 34 by the pressing apparatus 101, no gap is produced
between the joint member 3 and the connection section 46 of the
outer tube 34. In this manner, foaming will not occur in the joint
member 3 when the joint member 3 is heated. As a result,
transparency is provided to the joint section without deteriorating
aesthetic, and at the same time, the joint member 3 and the needle
2 as well as the joint member 3 and the connection section 46 of
the outer tube 34 can tightly be fixed.
Further, regarding the injection molding of the outer tube, since
the piece formed by injection molding is far smaller than the piece
made by directly forming the needle on the outer tube by insert
molding, the molding apparatus can be downsized, thereby reducing
the cost of facility.
[Comparative Experiment]
Next, the description will be made for a comparative experiment in
which cases with and without pressing of the joint member 3 in the
welding process using the semiconductor laser irradiation apparatus
120 are compared.
The output of the semiconductor laser irradiation apparatus 120 is
set to be 15 W or 20 W. The irradiation time of a laser is set to
be 1.5 to 3 seconds. Further, the focus diameter of the
semiconductor laser irradiation apparatus 120 is set to be .PHI. 3
mm for every case. The location which is irradiated with a laser is
set in the middle of the joint section, specifically, 5 to 6 mm
from the distal end (distal end side engagement portion 19 side) of
the connection section 16. The needle 2 of 27G is used and the
thickness of the joint member 3 is provided to be 0.47 mm.
The experiment is evaluated by "external appearance" and "joint
strength". The "external appearance" is evaluated to be good
(.largecircle.) when there is no foaming or burning and the length
of the welded section is 2 mm or more. Further, "joint strength" is
expressed by force (N) required to remove the joint member 3 from
the connection section 46 of the outer tube 34. It is sufficient to
have the "joint strength" of 50 N or higher, preferably, 80 to 120
N.
The result of the comparative experiment is illustrated in Table
2.
TABLE-US-00002 TABLE 2 Welding condition Laser output Welding
Result of welding Energy Time pressure External Joint (W) (sec) (N)
appearance strength (N) Example 3 20 1.5 80 .largecircle. 115
Example 4 20 2 80 .largecircle. 120 Example 5 15 3 80 .largecircle.
120 Comparative 20 1.5 0 X (Foaming) 60 example 2
As shown in Table 2, evaluations of "external appearance" for
Example 3, Example 4, and Example 5 which include pressing of the
joint member 3 are good (.largecircle.). And "joint strength" is
115 to 120 N.
Contrarily, for Comparative example 2 which doesn't include
pressing of the joint member 3, the evaluation of "external
appearance" is not good (x) since foaming occurred in the welded
portion. And joint strength between the joint member 3 and the
connection section 46 of the outer tube 34 is 60 N.
According to the comparative experiment, the case in which thermal
welding is carried out with the joint member 3 pressed resulted in
better "external appearance" than the case in which the joint
member 3 is not pressed. Further, in the case when thermal welding
is carried out with the joint member 3 pressed, it is confirmed
that the joint member 3 and the connection section 46 of the outer
tube 34 are firmly joined. Note that, it can be understood that in
Comparative example 2, the foaming occurred in the welded portion
resulting in reduction of the length of the welded portion, thereby
reducing joint strength between the joint member 3 and the outer
tube 34.
3. Third Embodiment of the Needle-Equipped Outer Tube
<Configuration of a Needle-Equipped Outer Tube>
Next, a third embodiment of the needle-equipped outer tube is
described referring to FIG. 11.
FIG. 11 is an explanatory drawing explaining the third embodiment
of the needle-equipped outer tube.
A needle-equipped outer tube 51 which is the third embodiment has a
configuration similar to that of the needle-equipped outer tube 31
of the second embodiment (see FIG. 8). The needle-equipped outer
tube 51 is different from the needle-equipped outer tube 31 in the
shape of a joint member 53 and the shape of a connection section 56
of an outer tube 54.
[Joint Member]
As illustrated in FIG. 11, the joint member 53 is formed in a
truncated conical shape and includes a tubular hole (needle
insertion hole) 53a in which the needle 2 is inserted. The diameter
of the tubular hole 53a is larger than the outer diameter of the
needle 2 by about 0.01 to 0.08 mm, preferably, by about 0.01 to
0.03 mm. The plane surface of the joint member 53 having larger
diameter is referred to as a distal end surface 53b and the plane
surface having smaller diameter is referred to as a rear end
surface 53c. The distal end surface 53b is a press force receiving
surface which is pressed by the pressing portion 101a (see FIG. 11)
of the pressing apparatus 101.
As a material of the joint member 53, a resin similar to that used
for the joint member 3 according to the first and second
embodiments is preferably used. Further, it is preferable that the
material of the joint member 53 is substantially transparent so
that the inside of the joint member 53 is visible.
[Outer Tube]
The outer tube 54 includes the outer tube body 15 in which a
medicine is filled and a connection section 56 to which the joint
member 53 is joined. The connection section 56 is configured with a
proximal end side engagement portion 58 which is continued to the
end portion 15b of the outer tube body 15 and a distal end side
engagement portion 59 which is continued to the proximal end side
engagement portion 58.
The proximal end side engagement portion 58 is formed in a
truncated conical shape. The diameter of the proximal end side
engagement portion 58 gradually decreases toward the distal end
side engagement portion 59. Therefore, the proximal end side
engagement portion 58 is formed so as that the cross section
perpendicular to the axial direction of the outer tube 54 is a near
circle.
The distal end side engagement portion 59 is formed in an
approximately column shape. The axis of the proximal end side
engagement portion 58 and the axis of the distal end side
engagement portion 59 are identical to the axis of the outer tube
body 15. Further, the cap 5 (see FIG. 4) engages with the distal
end side engagement portion 59.
In the connection section 56, an engagement hole 56a which runs
throughout the distal end side engagement portion 59 and the
proximal end side engagement portion 58 is formed. The engagement
hole 56a is formed in a tapered shape (tapered inner shape) having
a circular cross section of which diameter gradually decreases
toward the end portion 15b of the outer tube body 15. The joint
member 53 is inserted in the engagement hole 56a. In this manner,
the joint member 53 engages with the connection section 56 via the
tapered shape.
The joint member 53 is formed in a tapered shape (tapered outer
shape) so as to engage with the engagement hole 56a. Further, taper
angles of the engagement hole 56a and the joint member 53 are not
particularly limited, though an angle of 1 to 3 degrees is
preferable.
Note that, the proximal end side engagement portion 58 of the
connection section 56 may include the needle stopping portion 21
(see FIG. 6) thereinside. By providing the needle stopping portion
21 inside the proximal end side engagement portion 58, the needle 2
is positioned against the joint member 53 and the outer tube 54,
and the proximal end 2b of the needle 2 is arranged in the
connection section 56. As a result, the dead volume in the outer
tube 54 can be reduced, thereby reducing the amount of medicine
remaining in the outer tube 54.
As a material of the outer tube 54 configured with the connection
section 56 and the outer tube body 15, a resin similar to that used
for the joint member 53 is preferably used. Further, it is
preferable that the material of the outer tube 54 is substantially
transparent so that the inside of the outer tube 54 is visible.
Further, the connection section 56 of the outer tube 54 and the
joint member 53 are joined by thermal welding. Therefore, it is
preferable that the material of the outer tube 54 is substantially
the same as the material of the joint member 53. In this manner,
preferable bondability between the connection section 56 and the
joint member 53 can be obtained so that the connection section 56
and the joint member 53 can firmly be fixed. Further, the welded
portion between the connection section 56 and the joint member 53
can be made inconspicuous so that aesthetic of the needle-equipped
outer tube 51 can be improved.
The needle-equipped outer tube 51 having the configuration as
described above can be manufactured using either the method for
manufacturing described in the first embodiment or the method for
manufacturing described in the second embodiment. Consequently, the
needle 2 (not shown in the drawing) can be fixed to the outer tube
54 without using an adhesive.
Further, since the thermal welding is carried out with the distal
end surface 53b of the joint member 53 pressed along the axial
direction of the outer tube 54 by the pressing apparatus 101, no
gap is produced between the joint member 53 and the connection
section 56 of the outer tube 54. Therefore, foaming does not occur
in the joint member 53 when the joint member 53 is heated. As a
result, transparency is provided to the joint section without
deteriorating aesthetic, and at the same time, the joint member 53
and the needle 2 (not shown in the drawing) as well as the joint
member 53 and the connection section 56 of the outer tube 54 can
tightly be fixed.
4. Fourth Embodiment of the Needle-Equipped Outer Tube
<Configuration of a Needle-Equipped Outer Tube>
Next, the fourth embodiment of the needle-equipped outer tube will
be described referring to FIG. 12.
FIG. 12 is an explanatory drawing of the fourth embodiment of the
needle-equipped outer tube.
A needle-equipped outer tube 61 which is the fourth embodiment has
a configuration similar to that of the needle-equipped outer tube
31 of the second embodiment (see FIG. 8). The needle-equipped outer
tube 61 is different from the needle-equipped outer tube 31 in the
shape of a joint member 63 and the shape of a connection section 66
of an outer tube 64.
[Joint Member]
As illustrated in FIG. 12, the joint member 63 is formed in a
truncated quadrangular pyramid and includes a tubular hole (needle
insertion hole) 63a in which the needle 2 is inserted. The diameter
of the tubular hole 63a is larger than the outer diameter of the
needle 2 by about 0.01 to 0.08 mm, preferably, by about 0.01 to
0.03 mm. The plane surface of the joint member 63 having larger
area is referred to as a distal end surface 63b, and the plane
surface having smaller area is referred to as a rear end surface
63c. The distal end surface 63b is a press force receiving surface
which is pressed by the pressing portion 101a (see FIG. 11) of the
pressing apparatus 101.
As a material of the joint member 63, a resin similar to that used
for the joint member 3 according to the first and second
embodiments is preferably used. Further, it is preferable that the
material of the joint member 63 is substantially transparent so
that the inside of the joint member 63 is visible.
[Outer Tube]
The outer tube 64 includes the outer tube body 15 in which a
medicine is filled and a connection section 66 to which the joint
member 63 is joined. The connection section 66 is configured with a
proximal end side engagement portion 68 which is continued to the
end portion 15b of the outer tube body 15 and a distal end side
engagement portion 69 which is continued to the proximal end side
engagement portion 68.
The proximal end side engagement portion 68 is formed in a
truncated conical shape. The diameter of the proximal end side
engagement portion 68 gradually decreases toward the distal end
side engagement portion 69. Therefore, the proximal end side
engagement portion 68 is formed so as that the cross section
perpendicular to the axial direction of the outer tube 64 is a near
circle. Note that, the proximal end side engagement portion 68 may
include the needle stopping portion 21 (see FIG. 6)
thereinside.
The distal end side engagement portion 69 is formed in an
approximately column shape. The axis of the proximal end side
engagement portion 68 and the axis of the distal end side
engagement portion 69 are identical to the axis of the outer tube
body 15. Further, the cap 5 (see FIG. 4) engages with the distal
end side engagement portion 69.
In the connection section 66, an engagement hole 66a which runs
throughout the distal end side engagement portion 69 and the
proximal end side engagement portion 68 is formed. The engagement
hole 66a is formed in a tapered shape (tapered inner shape) having
a rectangular cross section of which contour gradually decreases
toward the end portion 15b of the outer tube body 15. The joint
member 63 is inserted in the engagement hole 66a. In this manner,
the joint member 63 engages with the connection section 66 via the
tapered shape.
The joint member 63 is formed in a tapered shape (tapered outer
shape) so as to engage with the engagement hole 66a. Further, taper
angles of the engagement hole 66a and the joint member 63 are not
particularly limited, though an angle of 1 to 3 degrees is
preferable.
As a material of the outer tube 54 configured with the connection
section 66 and the outer tube body 15, a resin similar to that used
for the joint member 63 is preferably used. Note that, it is
preferable that the material of the outer tube 64 is substantially
transparent so that the inside of the outer tube 64 is visible.
Further, the connection section 66 of the outer tube 64 and the
joint member 63 are joined by thermal welding. Therefore, it is
preferable that the material of the outer tube 64 is substantially
the same as the material of the joint member 63.
The needle-equipped outer tube 61 having the configuration as
described above can be manufactured using either the method for
manufacturing described in the first embodiment or the method for
manufacturing described in the second embodiment. As a result, the
needle 2 (not shown in the drawing) is fixed to the outer tube 64
without using an adhesive.
Further, since the thermal welding is carried out with the distal
end surface 63b of the joint member 63 pressed along the axial
direction of the outer tube 64 by the pressing apparatus 101, no
gap is produced between the joint member 63 and the connection
section 66 of the outer tube 64. Therefore, foaming does not occur
in the joint member 63 when the joint member 63 is heated. As a
result, transparency is provided to the joint section without
deteriorating aesthetic, and at the same time, the joint member 63
and the needle 2 (not shown in the drawing) as well as the joint
member 63 and the connection section 66 of the outer tube 64 can
tightly be fixed.
5. Fifth Embodiment of the Needle-Equipped Outer Tube
<Configuration of a Needle-Equipped Outer Tube>
Now, the fifth embodiment of the needle-equipped outer tube will be
described referring to FIG. 13. FIG. 13 is an explanatory drawing
of the fifth embodiment of the needle-equipped outer tube.
A needle-equipped outer tube 71 which is the fifth embodiment has a
configuration similar to that of the needle-equipped outer tube 31
of the second embodiment (see FIG. 8). The needle-equipped outer
tube 71 is different from the needle-equipped outer tube 31 in the
shape of a joint member 73 and the shape of a connection section 76
of an outer tube 74.
[Joint Member]
As illustrated in FIG. 13, the joint member 73 is formed in a
polygonal columnar shape so as to have a hexagram cross section in
a direction perpendicular to the axial direction. The joint member
73 includes a tubular hole (needle insertion hole) 73a in which the
needle 2 (not shown in the drawing) is inserted. The diameter of
the tubular hole 73a is larger than the outer diameter of the
needle 2 by about 0.01 to 0.08 mm, preferably, by about 0.01 to
0.03 mm.
The joint member 73 is formed in a tapered shape of which contour
gradually decreases from the end portion toward the other end
portion along the axial direction. The plane surface of the joint
member 73 on the end along the axial direction having larger area
is referred to as a distal end surface 73b, and the plane surface
on the other end having smaller area is referred to as a rear end
surface 73c. The distal end surface 73b is a press force receiving
surface which is pressed by the pressing portion 101a (see FIG. 11)
of the pressing apparatus 101.
As a material of the joint member 73, a resin similar to that used
for the joint member 3 according to the first and second
embodiments is preferably used. Further, it is preferable that the
material of the joint member 73 is substantially transparent so
that the inside of the joint member 73 is visible.
[Outer Tube]
The outer tube 74 includes the outer tube body 15 in which a
medicine is filled and the connection section 76 to which the joint
member 73 is joined. The connection section 76 is configured with a
proximal end side engagement portion 78 which is continued to the
end portion 15b of the outer tube body 15 and a distal end side
engagement portion 79 which is continued to the proximal end side
engagement portion 78.
The proximal end side engagement portion 78 is formed in a
truncated conical shape. The diameter of the proximal end side
engagement portion 78 gradually decreases toward the distal end
side engagement portion 79. Therefore, the proximal end side
engagement portion 78 is formed so as that the cross section
perpendicular to the axial direction of the outer tube 74 is a near
circle. Note that, the proximal end side engagement portion 78 may
include the needle stopping portion 21 (see FIG. 6)
thereinside.
The distal end side engagement portion 79 is formed in an
approximately column shape. The axis of the proximal end side
engagement portion 78 and the axis of the distal end side
engagement portion 79 are identical to the axis of the outer tube
body 15. Further, the cap 5 (see FIG. 4) engages with the distal
end side engagement portion 79.
In the connection section 76, an engagement hole 76a which runs
throughout the distal end side engagement portion 79 and the
proximal end side engagement portion 78 is formed. The engagement
hole 76a is formed in a tapered shape (tapered inner shape) having
a hexagram cross section of which contour gradually decreases
toward the end portion 15b of the outer tube body 15. The joint
member 73 is inserted in the engagement hole 76a. In this manner,
the joint member 73 engages with the connection section 76 via the
tapered shape.
The joint member 73 is formed in a tapered shape (tapered outer
shape) so as to engage with the engagement hole 76a. Further, taper
angles of the engagement hole 76a and the joint member 73 are not
particularly limited, though an angle of 1 to 3 degrees is
preferable.
As a material of the outer tube 74 configured with the connection
section 76 and the outer tube body 15, a resin similar to that used
for the joint member 73 is preferably used. Note that, it is
preferable that the material of the outer tube 74 is substantially
transparent so that the inside of the outer tube 74 is visible.
Further, the connection section 76 of the outer tube 74 and the
joint member 73 are joined by thermal welding. Therefore, it is
preferable that the material of the outer tube 74 is substantially
the same as the material of the joint member 73.
The needle-equipped outer tube 71 having the configuration as
described above can be manufactured using either the method for
manufacturing described in the first embodiment or the method for
manufacturing described in the second embodiment. As a result, the
needle 2 (not shown in the drawing) is fixed to the outer tube 74
without using an adhesive.
Further, since the thermal welding is carried out with the distal
end surface 73b of the joint member 73 pressed along the axial
direction of the outer tube 74 by the pressing apparatus 101, no
gap is produced between the joint member 73 and the connection
section 76 of the outer tube 74. Therefore, foaming does not occur
in the joint member 73 when the joint member 73 is heated. As a
result, transparency is provided to the joint section without
deteriorating aesthetic, and at the same time, the joint member 73
and the needle 2 (not shown in the drawing) as well as the joint
member 73 and the connection section 76 of the outer tube 74 can
tightly be fixed.
6. Sixth Embodiment of the Needle-Equipped Outer Tube
<Configuration of a Needle-Equipped Outer Tube>
Next, the sixth embodiment of the needle-equipped outer tube will
be described referring to FIG. 14.
FIG. 14 is an explanatory drawing of the sixth embodiment of the
needle-equipped outer tube.
A needle-equipped outer tube 81 which is the sixth embodiment has a
configuration similar to that of the needle-equipped outer tube 31
of the second embodiment (see FIG. 8). The needle-equipped outer
tube 81 is different from the needle-equipped outer tube 31 in the
shape of a joint member 83 and the shape of a connection section 86
of an outer tube 84.
[Joint Member]
As illustrated in FIG. 14, the joint member 83 is formed in an
approximately cylindrical shape having a tubular hole (needle
insertion hole) 83a in which the needle 2 is inserted. The diameter
of the tubular hole 83a is larger than the outer diameter of the
needle 2 (not shown in the drawing) by about 0.01 to 0.08 mm,
preferably, by about 0.01 to 0.03 mm.
The joint member 83 is configured with a distal end side tubular
portion 84 and a rear end side tubular portion 85 having an outer
diameter smaller than that of the distal end side tubular portion
84. The distal end side tubular portion 84 is formed in a
cylindrical shape having a uniform outer diameter.
On the end portion, opposite to the rear end side tubular portion
85, of the distal end side tubular portion 84, a distal end surface
84a is formed. The distal end surface 84a is a press force
receiving surface which is pressed by the pressing portion 101a of
the pressing apparatus 101 which will be described below. On the
end portion, opposite to the rear end side tubular portion 84, of
the distal end side tubular portion 84, a contact surface 84b is
formed. The contact surface 84b makes contact with the connection
section 86 of the outer tube 84. Further, the cap 5 (see FIG. 4)
engages with the distal end side engagement portion 84.
The rear end side tubular portion 85 is formed in a truncated
conical shape. The diameter of the rear end side tubular portion 85
gradually decreases toward the end portion opposite to the distal
end side tubular portion 84. Further, on the end portion, opposite
to the distal end side tubular portion 84, of the rear end side
tubular portion 85, a rear end surface 85a is formed.
As a material of the joint member 83, a resin similar to that used
for the joint member 3 according to the first and second
embodiments is preferably used. Further, it is preferable that the
material of the joint member 83 is substantially transparent so
that the inside of the joint member 83 is visible.
[Outer Tube]
The outer tube 84 includes the outer tube body 15 in which a
medicine is filled and a connection section 86 to which the joint
member 83 is joined. The connection section 86 is continued to the
end portion 15b of the outer tube body 15.
The connection section 86 is formed, similarly to the tapered
engagement portion 48 (see FIG. 8) of the connection section 46
according to the second embodiment, in a truncated conical shape.
The diameter of the connection section 86 gradually decreases
toward the distal end side engagement portion 19.
The connection section 86 includes an engagement hole 86a. The
engagement hole 86a is formed in a tapered shape (tapered inner
shape) in which the diameter gradually decreases toward the end
portion 15b of the outer tube body 15. The rear end side tubular
portion 85 of the joint member 83 is inserted in the engagement
hole 86a. In this manner, the rear end side tubular portion 85 of
the joint member 83 engages with the connection section 86 via the
tapered shape. Note that, the connection section 86 may include the
needle stopping portion 21 (see FIG. 6) thereinside.
The rear end side tubular portion 85 of the joint member 83 is
formed in a tapered shape (tapered outer shape) so as to engage
with the engagement hole 86a. Further, taper angles of the
engagement hole 86a and the rear end side tubular portion 85 are
not particularly limited, though an angle of 1 to 3 degrees is
preferable.
As a material of the outer tube 84 configured with the connection
section 86 and the outer tube body 15, a resin similar to that used
for the joint member 83 is preferably used. Note that, it is
preferable that the material of the outer tube 84 is substantially
transparent so that the inside of the outer tube 84 is visible.
Further, the connection section 86 of the outer tube 84 and the
rear end side tubular portion 85 of the joint member 83 are joined
by thermal welding. Therefore, it is preferable that the material
of the outer tube 84 is substantially the same as the material of
the joint member 83.
The needle-equipped outer tube 81 having the configuration as
described above can be manufactured using either the method for
manufacturing described in the first embodiment or the method for
manufacturing described in the second embodiment. As a result, the
needle 2 (not shown in the drawing) is fixed to the outer tube 84
without using an adhesive.
Further, since the thermal welding is carried out with the distal
end surface 84a of the joint member 83 pressed along the axial
direction of the outer tube 84 by the pressing apparatus 101, no
gap is produced between the rear end side tubular portion 85 of the
joint member 83 and the connection section 86 of the outer tube 84.
Therefore, foaming does not occur in the rear end side tubular
portion 85 when the rear end side tubular portion 85 of the joint
member 83 is heated. As a result, transparency is provided to the
joint section without deteriorating aesthetic, and at the same
time, the joint member 83 and the needle 2 (not shown in the
drawing) as well as the rear end side tubular portion 85 of the
joint member 83 and the connection section 86 of the outer tube 84
can tightly be fixed.
7. Seventh Embodiment of the Needle-Equipped Outer Tube
<Configuration of a Needle-Equipped Outer Tube>
Next, the seventh embodiment of the needle-equipped outer tube will
be described referring to FIG. 15.
FIG. 15 is an explanatory drawing of the seventh embodiment of the
needle-equipped outer tube.
A needle-equipped outer tube 91 which is the seventh embodiment has
a configuration similar to that of the needle-equipped outer tube
51 of the third embodiment (see FIG. 11). The needle-equipped outer
tube 91 is different from the needle-equipped outer tube 51,
solely, in the shape of a joint member 93.
As illustrated in FIG. 15, the joint member 93 of the
needle-equipped outer tube 91 is formed, similarly to the joint
member 53 according to the third embodiment, in a truncated conical
shape. The joint member 93 includes a tubular hole 93a, a distal
end surface 93b, a rear end surface 93c, and an outer
circumferential surface 93d.
Further, substantially same transparent materials are used for
materials of the joint member 93 and the outer tube 54.
Roughening process is applied to the outer circumferential surface
93d of the joint member 93.
As the method of roughening process applied to the outer
circumferential surface of the joint member 93, for example, a
method of transferring the roughness provided on a mold for forming
the joint member 93 may be used. Further, blasting may be applied
after forming the joint member 93 having a smooth outer
circumferential surface. Further, the roughness of the outer
circumferential surface of the joint member 93, after roughening
process is applied, is preferably, for example, Ra 0.1 to 3.
Further, satin process or embossing process may be applied to the
outer circumferential surface 93d of the joint member 93.
The needle-equipped outer tube 91 having the configuration as
described above can be manufactured using either the method for
manufacturing described in the first embodiment or the method for
manufacturing described in the second embodiment. Consequently, the
needle 2 (not shown in the drawing) can be fixed to the outer tube
54 without using an adhesive.
Further, since the thermal welding is carried out with the distal
end surface 93a of the joint member 93 pressed along the axial
direction of the outer tube 54 by the pressing apparatus 101, no
gap is produced between the joint member 93 and the connection
section 56 of the outer tube 54. Therefore, foaming does not occur
in the joint member 93 when the joint member 93 is heated. As a
result, transparency is provided to the joint section without
deteriorating aesthetic, and at the same time, the joint member 93
and the needle 2 (not shown in the drawing) as well as the joint
member 93 and the connection section 56 of the outer tube 54 can
tightly be fixed.
Further, as for the joint section between the joint member 93 and
the connection section 56, the welded portion becomes transparent
and the portion which is not welded becomes nontransparent.
Therefore, it can easily be recognized whether the welded state
between the joint member 93 and the connection section 56 is
good.
In the embodiment, roughening process is applied to the outer
circumferential surface of the joint member 93. However, roughening
process can be applied to the inner circumferential surface of the
connection section 53 to manufacture the needle-equipped outer tube
of the present invention. Further, the roughening process applied
in the embodiment can be applied in the first, second, and fourth
to sixth embodiments described above.
The present invention is not limited to the embodiments described
above and illustrated in the drawings. Various modifications can be
made without departing from the spirit and the scope of the present
invention described in the claims.
For example, in the first and second embodiments described above,
high frequency welding and laser welding are applied as specific
examples of thermal welding, though ultrasonic welding can be
applied as the thermal welding according to embodiments of the
present invention.
Further, the outer tube 4 of the first embodiment described above
can be replaced with the outer tube 34 of the second embodiment
described above. Similarly, the outer tube 34 of the second
embodiment can be replaced with the outer tube 4 of the first
embodiment.
Further, in the first embodiment described above, the cross section
of the tapered engagement portion 18 of the connection section 16
is formed in an approximate cross-shape, and in the second to
seventh embodiments described above, the cross section of the
tapered engagement portion of the connection section is formed in a
near circle (approximately cylindrical shape). However, the cross
section of the connection section according to the present
invention may be a polygon such as a triangle and a rectangle, or
may be other shapes such as an ellipse and a half circle.
Further, in the first to seventh embodiments described above, the
joint member is configured to engage with the connection section
via the tapered shape. However, in the method for manufacturing the
needle-equipped outer tube of the present invention, it is not
limited to the engagement via the tapered shape as long as the
joint member and the connection section engage with each other
during thermal welding. Note that, it is effective to engage the
joint member and the connection section via the tapered shape, in
that a gap (clearance) between the joint member and the connection
section can be eliminated or made small, thereby preventing foaming
during the thermal welding.
Further, in the first to seventh embodiments described above, the
shape of the joint member is formed in a truncated conical shape, a
truncated quadrangular pyramid, or a polygonal columnar shape
(hexagram). However, the shape of the joint member according to
embodiments of the present invention may suitably be modified as
long as the shape allows joining to the connection section.
* * * * *